Bioreactors support a biologically active environment for conducting a bio-chemical process involving biological organisms or biochemically active substances derived from such organisms. Bioreactor design is a complex engineering task requiring fine-tuning of bioreactor design and operational configuration to enable the cultured organisms to achieve their desired function. Before large-scale commercial manufacturing can be implemented, it is typically necessary to scale up a bioreactor during a process development stage. However, conventional scale-up techniques are fraught with technical challenges and financial risks.
Conventional techniques, for example, involve many steps of volume increases using different volumes of bioreactors. Control and test methods must be performed at each scale-up step as mass transfer of fluid tends to cause reduction in performance. Scale-up engineering involved in scaling up from the bench scale (i.e., a few liters) to the manufacturing scale (i.e., a couple of thousand liters) is complex, and it is difficult to ensure reproducibility of operation and performance at each scale-up step. Due to variability in operational and performance characteristics at each scale-up step, it is also challenging to satisfy regulatory and safety requirements using conventional scale-up techniques. Furthermore, in conventional scale-up, bioreactor components must be sterilized at each scale-up step.